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Advanced MalignanciesPhase 1NCT04025957

A Study of SHR-1501 in Patients With Advanced Tumors

A Phase 1 study testing SHR-1501 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies . Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Malignancies
What is being tested?
SHR-1501
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
30 Oct 2019to 31 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All Patients All patients must meet all the following criteria to be eligible to participate:
  • Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
  • Subjects must be willing and able to follow the research protocol;
  • Aged 18-70 years old when the informed consent form is signed;
  • Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
  • Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
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  • Eastern Cooperative Oncology Group ECOG PS score of 0-1;
  • Have a life expectancy of ≥ 12 weeks;
  • Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
  • Non-surgically sterilized women of childbearing age or male subjects are required to consent to the use of at least one medically approved contraceptive (eg intrauterine devices, contraceptives or condoms) is performed during the study treatment period and within 3 months of the end of the study treatment period.

Who cannot join

  • Patients with cancerous meningitis (ie meningeal metastasis);
  • Patients with active central nervous system (CNS) metastasis.
  • Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
  • Patients with double primary cancers;
  • Patients with a history of autoimmune diseases;
  • Significant clinical significance in the history of cardiovascular disease;
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  • Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
  • Have a history of immunodeficiency including HIV infection;
  • Active hepatitis B or hepatitis C patients;
  • Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator.;
  • Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics);
  • Those who used a live attenuated vaccine within 4 weeks prior to the first dose or expect a live attenuated vaccine during the study period;
  • Those who received other clinical trials within 4 weeks prior to the first study;
  • Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose;
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  • A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs;
  • Mental illness, alcohol abuse, drug abuse or substance abuse;
  • Any disease or condition that causes reasonable suspicion to prohibit the use of the study drug or affect the interpretation of the study results or the patient is at high risk of treatment complications (any other disease, metabolic disorder, physical examination results or laboratory tests abnormalities);
  • Pregnant or lactating women or women planning to become pregnant during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer hospital, Chinese academy of medical sciences

    Beijing, 100021

Other trials in China

About this study

Official title: A Phase I Study on Tolerance, Safety and Pharmacokinetics of SHR-1501 in Patients With Advanced Malignancies.

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies .

Being tested
SHR-1501

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1501Drug

    Administered subcutaneously

Study groups in NCT04025957
Study groupRoleWhat they receive
SHR-1501 dose escalationExperimentalSHR-1501 given subcutaneously
Receives: Drug: SHR-1501
SHR-1501 dose expansionExperimentalSHR-1501 given subcutaneously
Receives: Drug: SHR-1501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity

    Dose-limiting toxicity in patients with advanced tumors treated by SHR-1501.

    Measured: Approximately 2 years

  2. Maximum tolerated dose

    Maximum tolerated dose in patients with advanced tumors treated by SHR-1501.

    Measured: Approximately 2 years

  3. Adverse event/Serious adverse event

    Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0)

    Measured: Approximately 2 years

Secondary outcomes (21)

  1. Pharmacokinetic (PK)

    Single dose: maximum concentration (Cmax)

    Measured: Approximately 2 years

  2. Pharmacokinetic (PK)

    Single dose: time to maximum concentration (Tmax)

    Measured: Approximately 2 years

  3. Pharmacokinetic (PK)

    Single dose: areas under the concentration-time curve (AUClast and AUCinf)

    Measured: Approximately 2 years

  4. Pharmacokinetic (PK)

    Single dose: half-life (t1/2)

    Measured: Approximately 2 years

  5. Pharmacokinetic (PK)

    Single dose: clearance (CL)

    Measured: Approximately 2 years

  6. Pharmacokinetic (PK)

    Single dose: mean residence time (MRT)

    Measured: Approximately 2 years

  7. Pharmacokinetic (PK)

    Single dose: volume at steady state (Vss)

    Measured: Approximately 2 years

  8. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): maximum concentration at steady state （Css_max）

    Measured: Approximately 2 years

  9. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):time to maximum concentration （Tmax）

    Measured: Approximately 2 years

  10. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):area under the concentration-time curve at steady state （AUCss）

    Measured: Approximately 2 years

  11. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): t1/2

    Measured: Approximately 2 years

  12. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):steady-state minimum concentration at steady state （Css_min）

    Measured: Approximately 2 years

  13. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):average concentration at steady state（Cavg）

    Measured: Approximately 2 years

  14. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):accumulation ratio （Rac）

    Measured: Approximately 2 years

  15. Immune-related biomarkers

    indicated by the count of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  16. Immune-related biomarkers

    indicated by the percentage of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  17. Immune-related biomarkers

    indicated by the count of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  18. Immune-related biomarkers

    indicated by the percentage of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  19. Objective response rate

    Percentage of participants with CR or PR.

    Measured: Approximately 2 years

  20. Disease control rate

    Percentage of participants with CR or PR or SD.

    Measured: Approximately 2 years

  21. Immunogenicity

    The immunogenicity of SHR-1501 single drug. The indicator includes number of participants with anti-drug antibody positive or neutralizing antibody positive.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start30 Oct 2019
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025957
Sponsor's protocol ID
SHR-1501-I-102
Status last verified
Jul 2020
First submitted
14 Jul 2019
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1501 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: Approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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